Recall Z-2743-2018 ยท LTI Implant, Intragastric For Morbid Obesity
Apollo Endosurgery Inc
Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap-Band system consists of a silicone band with pillows that are filled with saline and a buckle that joins the ends of the bands together, an access port and silicone tubing that connects the band to the access port. The band is placed laparoscopically around the stomach, creating a small pouch or stoma, thereby limiting food
| Date | Nov 22, 2017 |
| Status | Terminated |
| Reason | Component of the Lap-Band system was missing from the package |
| Root cause | Under Investigation by firm |
| Action | Consignees were initially contacted via telephone and later via letter. The firms letter requested the hospital risk manager dispose of the defective product. |
| Quantity | 54 |
| Distribution | Worldwide Distribution - FL, IL, LA, MI, MO, NC, NY, TN, TX, VA and WV and the countries of France, Italy, Spain, and United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.